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Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

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ClinicalTrials.gov Identifier: NCT03281200
Recruitment Status : Completed
First Posted : September 13, 2017
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Retrospective
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: L - Antineoplastic and immunomodulating agents
Drug: L01 - Antineoplastic agents
Drug: L01X - Other antineoplastic agents
Drug: L01XE - Protein kinase inhibitors
Drug: L01XE31 - Nintedanib
Enrollment 172
Recruitment Details Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.
Pre-assignment Details All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Period Title: Overall Study
Started [1] 172
Completed 172
Not Completed 0
[1]
Started are the treated with entry criteria met
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Baseline Participants 172
Hide Baseline Analysis Population Description
All enrolled patients who met the selection criteria.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants
71.0  (8.1)
[1]
Measure Description: Age at the time of baseline visit
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Particpants
Male Number Analyzed 172 participants
131
Female Number Analyzed 172 participants
40
No data Number Analyzed 172 participants
1
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
[1]
Measure Analysis Population Description: Ethnicity data was not collected for this trial.
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 172 participants
170
Asiatic Number Analyzed 172 participants
1
Arab Number Analyzed 172 participants
1
1.Primary Outcome
Title Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
Hide Description The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentage of Patients (%)
Mild IPF: FVC ≥ 70% 57.0
Moderate IPF: FVC between 50% and 69% 38.4
Severe IPF: FVC < 50% 4.7
2.Primary Outcome
Title Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
Hide Description The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 153
Measure Type: Number
Unit of Measure: Percentage of Patients (%)
Mild IPF: DLCO ≥ 50% 42.5
Moderate IPF: DLCO between 35% and 49% 35.3
Severe IPF: DLCO < 35% 22.2
3.Secondary Outcome
Title The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
Hide Description The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: Years
70.1  (8.1)
4.Secondary Outcome
Title The Clinical Baseline Characteristics - Duration of the Disease
Hide Description Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: Years
1.5  (3.8)
5.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
Hide Description The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
No 84.3
Yes 15.7
6.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
Hide Description The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
No 13.4
Yes 30.8
No data 55.8
7.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
Hide Description The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
No 9.9
Yes 89.0
No data 1.2
8.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
Hide Description The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
150 mg/12 h 88.4
100 mg/12 h 11.0
No data 0.6
9.Secondary Outcome
Title The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
Hide Description The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 160
Mean (Standard Deviation)
Unit of Measure: Kilogram (Kg)
77.1  (13.2)
10.Secondary Outcome
Title The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
Hide Description The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Centimeters (cm)
164.5  (8.9)
11.Secondary Outcome
Title The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
Hide Description The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Kilogram/ meter^2 (kg/m^2)
28.4  (3.8)
12.Secondary Outcome
Title The Demographic Baseline Characteristics - 6-minute Walk Test
Hide Description The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 136
Mean (Standard Deviation)
Unit of Measure: Meter (m)
421.7  (118.6)
13.Secondary Outcome
Title The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
Hide Description The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentage of Participants
Never smoker 33.1
Former smoker 64.0
Active smoker 2.9
14.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
Hide Description The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Partients
No 5.2
Yes 93.0
No data 1.7
15.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
Hide Description The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of patients
No 84.9
Yes 11.6
No data 3.5
16.Secondary Outcome
Title The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
Hide Description The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
No 20.3
Yes 79.7
17.Secondary Outcome
Title Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
Hide Description The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
Hypertension 45.9
Dyslipidaemia 42.4
Gastroesophageal reflux 25.6
Diabetes mellitus 19.8
Emphysema 15.7
Cardiovascular disease 15.7
Obstructive sleep apnoea 11.6
Pulmonary hypertension 5.8
Lung cancer 1.7
Pulmonary infection 1.2
18.Secondary Outcome
Title Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
Hide Description The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
41.9
19.Secondary Outcome
Title Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
Hide Description The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).
Time Frame From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients who met the selection criteria.
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description:
The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: Percentages of Patients
Mild IPF: FVC > 80% 33.1
Moderate IPF: FVC between 50% and 80% 62.2
Severe IPF: FVC < 50% 4.7
Time Frame From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days
Adverse Event Reporting Description Patients who enrolled in the study and met the selection criteria used for reporting adverse events
 
Arm/Group Title Total Patients With IPF
Hide Arm/Group Description The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
All-Cause Mortality
Total Patients With IPF
Affected / at Risk (%)
Total   10/172 (5.81%) 
Show Serious Adverse Events Hide Serious Adverse Events
Total Patients With IPF
Affected / at Risk (%)
Total   13/172 (7.56%) 
Cardiac disorders   
Acute coronary syndrome * 1  1/172 (0.58%) 
Cardiac failure congestive * 1  1/172 (0.58%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/172 (0.58%) 
General disorders   
Death * 1  2/172 (1.16%) 
Hepatobiliary disorders   
Hepatotoxicity * 1  1/172 (0.58%) 
Infections and infestations   
Pneumonia pneumococcal * 1  1/172 (0.58%) 
Investigations   
Weight decreased * 1  1/172 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Transitional cell carcinoma * 1  1/172 (0.58%) 
Respiratory, thoracic and mediastinal disorders   
Idiopathic pulmonary fibrosis * 1  3/172 (1.74%) 
Pneumothorax * 1  1/172 (0.58%) 
Pulmonary arterial hypertension * 1  1/172 (0.58%) 
Vascular disorders   
Hypertensive crisis * 1  1/172 (0.58%) 
1
Term from vocabulary, MedDRA 21.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Patients With IPF
Affected / at Risk (%)
Total   38/172 (22.09%) 
Gastrointestinal disorders   
Diarrhoea * 1  38/172 (22.09%) 
1
Term from vocabulary, MedDRA 21.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03281200     History of Changes
Other Study ID Numbers: 1199-0295
First Submitted: September 11, 2017
First Posted: September 13, 2017
Results First Submitted: June 6, 2019
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019